NCT04829643

Axillary Staging in Early Breast Cancer: SNB vs PET/MRI

Completed NA Last updated 26 March 2025

What this trial tests

NA trial testing PET/MRI in Breast Cancer in 246 participants. Completed in 30 October 2024.

Timeline

1 June 2020

Primary endpoint
30 October 2024

30 October 2024

Quick facts

Lead sponsor	IRCCS San Raffaele
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	246
Start date	1 June 2020
Primary completion	30 October 2024
Estimated completion	30 October 2024
Sites	1 location across Italy

Drugs / interventions tested

• PET/MRI

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Sentinel Lymph Node — all drugs for Sentinel Lymph Node →
• Early-stage Breast Cancer — all drugs for Early-stage Breast Cancer →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Sentinel Lymph Node. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The gold standard of surgical treatment for patients with early breast cancer (BC) is breast conservation and sentinel node biopsy (SNB). Ongoing randomized trials are evaluating to omit surgery at all when axillary imaging is negative. However, the available diagnostic tools still have several limitations in accuracy.

Combining the specificity of PET, with the superior sensitivity of MRI, hybrid PET/MRI might be a non-invasive, one-stage, operator-independent imaging method to accurately define nodal status and, whenever negative, might replace surgery for axillary staging.

The project includes patients with \<3 cm BC without overt nodal involvement who will undergo PET/MRI prior to surgery. The primary aim is to compare the staging power between SNB and PET/MRI in detecting axillary lymph node macrometastases (\>2 mm). Additionally, general concordance and diagnostic accuracy of PET/MRI vs SNB, eventual correlation with BC molecular subtypes and MRI findings will be evaluated.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. PET/MRI for Staging the Axilla in Breast Cancer: Current Evidence and the Rationale for SNB vs. PET/MRI Trials.
   Di Micco R, Santurro L, Gasparri ML, Zuber V, et al · · 2021 · cited 13× · PMID 34298781 · DOI 10.3390/cancers13143571
2. PET/MRI and Novel Targets for Breast Cancer.
   Chung HW, Park KS, Lim I, Noh WC, et al · · 2024 · cited 4× · PMID 38255277 · DOI 10.3390/biomedicines12010172
3. [&lt;sup&gt;18&lt;/sup&gt;F]FDG PET/MRI vs sentinel node biopsy for axillary staging of early breast cancer patients. A prospective single-arm trial.
   Di Micco R, Botteri E, Canevari C, Gallivanone F, et al · · 2025 · cited 3× · PMID 40449294 · DOI 10.1016/j.ejca.2025.115519
4. Hybrid [&lt;sup&gt;18&lt;/sup&gt;F]FDG PET/MR Imaging Parameters for the Prediction of Tissue Biomarkers in Invasive Ductal Breast Cancer.
   Neri I, Gallivanone F, Venturini E, Canevari C, et al · · 2026 · PMID 42072229 · DOI 10.3390/bioengineering13040435